OncoMatch/Clinical Trials/NCT06990880
A Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostate Cancer
Official title: A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Expansion Study of GSK5458514 PSMA Targeting T Cell Engager Alone or in Combination With Other Anti-cancer Agents in Adult Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)
Is NCT06990880 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies GSK5458514 for neoplasms, prostate.
Treatment: GSK5458514 — The goal of the study is to evaluate how safe and how well the body handles GSK5458514 when administered in participants with prostate cancer. The study will be conducted in two parts - Part 1 (dose escalation phase) and Part 2 (dose expansion phase).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Prostate Cancer
Biomarker criteria
Required: PSMA (FOLH1) expression (testing required; no eligibility threshold specified)
retrospective detection of Prostate-specific membrane antigen (PSMA) expression and other biomarker analysis
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: antiandrogen — metastatic castration-resistant prostate cancer
prior novel anti-androgen receptor therapy failure
Must have received: taxane — including for metastatic hormone sensitive prostate cancer
treatment failure with 1-2 taxane-based chemotherapy regimens including for metastatic hormone sensitive prostate cancer
Cannot have received: PSMA CAR-T cell therapy
Prior PSMA-Chimeric antigen receptor T cell therapy (CAR-T) cell therapy
Cannot have received: PSMA T cell engager
PSMA (T cell engager) TCE/ Bispecific T cell engagers (BiTE) or other prostate Tumor-associated antigens (TAA) specific T cell engager (TCE)
Cannot have received: bone marrow transplant
any history of prior allogenic or autologous bone marrow transplant
Cannot have received: solid organ transplant
any history of prior ... solid organ transplant
Lab requirements
Liver function
ALT value >2.5x ULN or >5x ULN if documented history of liver metastases; total bilirubin value >1.5x ULN; cirrhosis or current unstable liver or biliary disease per investigator assessment
Liver safety exclusion criteria: ALT value >2.5x ULN or >5x ULN if documented history of liver metastases; total bilirubin value >1.5x ULN; cirrhosis or current unstable liver or biliary disease
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- GSK Investigational Site · Phoenix, Arizona
- GSK Investigational Site · Denver, Colorado
- GSK Investigational Site · New Haven, Connecticut
- GSK Investigational Site · Rochester, Minnesota
- GSK Investigational Site · East Brunswick, New Jersey
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06990880 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior PSMA CAR-T cell therapy, PSMA T cell engager, bone marrow transplant disqualifies patients from enrollment.
Does this trial require FOLH1?
Yes, FOLH1 expression is a required biomarker for enrollment.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify